Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE TRAY ID1765 ER I&D PACK ID1765 ER I&D PACK ID1835 I & D TRAY ID2075 I&D TRAY ID585 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY
This recall has been terminated (originally issued December 11, 2019).
- Recall Initiated
- December 11, 2019
- Terminated
- September 4, 2020
- Recall Number
- Z-1065-2020
- Firm Location
- Williamston, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Distribution
Nationwide Foreign: GHANA
Lot / Code Info
Lot Numbers: ID1235A ESKENAZI INCISION & DRAINAGE TRAY 2019020890 ID1525 INCISION & DRAINAGE TRAY 2019052890 ID1670 I&D TRAY 2019050890 ID1715 INCISION & DRAINAGE TRAY 2018121390 ID1765 ER I&D PACK 2019042290 ID1765 ER I&D PACK 2019021190 ID1835 I & D TRAY 2019041290 ID2075 I&D TRAY 2019052990 ID585 INCISION & DRAINAGE TRAY 2019022090 ID875 INCISION & DRAINAGE TRAY 2019020590 ID875 INCISION & DRAINAGE TRAY 2019011790
Root Cause
Packaging process control
Action Taken
Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.